Sr. Clinical Data Manager

G1 Therapeutics Durham, NC
G1 Therapeutics is seeking an experienced Sr. Clinical Manager to join the team.Responsibilities:

* Oversee and manage DM related activities outsourced to DM Vendors as well as other external data sources (e.g. central and/or specialty labs, IVR vendors, etc.) from study start-up to study close-out and final database lock/transfer while ensuring that all study deliverables and milestones are met on time and within budget

* Proactively organizes ongoing data review within clinical and biostatistics throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies

* Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts

* Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications

* Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, and CRF (eCRF) completion / monitoring conventions

* Develop and test data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities

* Participate with the Study Operations Teams (SOTs) for all study activities, and lead all DM functional activities by establishing rapport and maintaining positive, open communication within G1 and with external vendors

* Provide operational leadership to the direction, planning, execution, collection and handling of all clinical data to the highest quality standards

* Review study data for completeness and clinical sense. Assess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., increased frequency of queries, protocol deviations, and early treatment discontinuations

* Develop and manage the data review plan for each assigned study, including maintenance and tracking of findings from all team members through issue resolution and involving the data vendors as needed

* At all times, ensure the receipt and proper filing, security and archiving of study related data, both paper and electronic media

* Cultivate effective and productive working relationships with colleagues, subordinates, vendors and management by using clear judgment to solve problems and to escalate issues with proposed solutions, as necessary

Requirements:

* Bachelor's degree in a relevant scientific discipline or equivalent

* Minimum of 5 years of Data management experience in the pharmaceutical, biotech and/or CRO industries, with experience in managing data from Phase III clinical trials

* Skills present in core data management activities (e.g., Data Management Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of medical coding dictionaries)

* Knowledge and experience with various clinical databases (e.g., Medidata RAVE, Oracle InForm and key technologies (e.g., SAS, Scanning/Imaging, IVRS/IWRS, ePRO)

* Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required

* Excellent communication, written and interpersonal skills

* Self-sufficient and able to work with minimal oversight

* Demonstrate leadership skills and the ability to lead teams and motivate team members, as needed

* Able to prioritize and handle multiple tasks and studies simultaneously

* Able to manage indirect staff, as needed. Ability to develop project management objectives, as needed

* Proficiency with MS Word, Excel, Outlook, and PowerPoint, SAS programming a plus

* Must be willing to travel as required

G1 Therapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. G1 Therapeutics complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.